Benefits of Applying Neuroprosthesis for Improving Reaching and Grasping Functions in Stroke Patients

Stroke Clinical Trial

Official title:

Restoration of Reaching and Grasping Functions in Stroke Patients Using Functional Electrical Stimulation.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00221078
• Other study ID #: 88098-0461-RR001
• Secondary ID: 88098-0461-RR001
• Status: Completed
• Phase: Phase 3
• First received: September 14, 2005
• Last updated: February 4, 2009
• Start date: April 2003
• Est. completion date: December 2005

Study information

• Verified date: February 2009
• Source: Toronto Rehabilitation Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

Functional electrical stimulation (FES) is a process that uses low intensity electrical pulses generated by an electric stimulator to create muscle contractions. By contracting muscles in a specific sequence, one can generate various body functions such as grasping, walking, and standing. Final goal of the study is to evaluate if FES training when applied early during rehabilitation will help stroke patients to use their hands more effectively after discharge from a rehabilitation facility, compared to those patients who have not received FES training.

Description:

Neuroprosthesis are systems that apply functional electrical stimulation to cause muscle contractions. If the muscle contractions are sequenced properly one can generate various functions such as grasping, standing, and walking. Recent studies of others and our pilot study indicate that a neuroprosthesis can be successfully applied as a training device to help stroke patients who have hemiplegic arm to relearn how to reach and grasp various objects. The objective of this research program is to confirm these preliminary results with the broader population of stroke patients, and if successful to propose a method to introduce this rehabilitation treatment into Toronto Rehabilitation Institute, Stroke Unit as a primary intervention for hand function recovery. Specifically, our aim is to1)develop an exercise protocol that uses a neuroprosthesis for reaching and grasping developed by our team in combination with the standard physiotherapy treatments to enhance recovery of hemiplegic arm and hand; and 2) assess qualitatively and quantitatively improvements in the reaching and grasping functions achieved with standard rehabilitation treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2005
• Est. primary completion date: June 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patient must be motivated to participate in the FES study, and must sign the letter of consent.

• Patients must have hemiplegia and the stroke must be confirmed with a CT scan.

• Patients must understand that the role of this study is to enhance recovery and not to guarantee it.

Exclusion Criteria:

• Patients who is motivated and does not sign the letter of consent.

• Patient who has serious cognitive or psychological impairments.

• Patients who has skin rush, allergy or wounds.

• Alcohol or drug abuse.

• Edema in his/her upper extremity.

• Patients with Shoulder Hand Syndrome

• Global aphasia

• Patients who shows early recovery of the function.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• Neuroprosthesis
The Compex Motion neuroprosthesis, developed by Drs.R. Popovic and Thierry Keller, and company Compex SA, is a flexible device designed to improve grasping function in both SCI and stroke patients. This multi-channel surface stimulation system for grasping provides both palmar and lateral grasp, and holds a number of advantages over the other existing neuroprostesis.

Locations

Country	Name	City	State
Canada	Toronto Rehabilitation Institute	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Toronto Rehabilitation Institute	The Physicians' Services Incorporated Foundation

Country where clinical trial is conducted

Canada, 

References & Publications (1)

Popovic MR, Thrasher TA, Adams ME, Takes V, Zivanovic V, Tonack MI. Functional electrical therapy: retraining grasping in spinal cord injury. Spinal Cord. 2006 Mar;44(3):143-51. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	REL Hand Function Test		45 min	No
Primary	Fugl-Meyer Assessment		30 min	No
Secondary	Barthel Index		25 min	Yes
Secondary	Functional Independence Measure		25 min	Yes
Secondary	Chedoke-McMaster Stages of Motor Recovery		30 min	Yes

External Links

•   Rehabilitation Engineering Laboratory